U.S. FDA Grants Orphan Drug Status to PI-88 for Melanoma
03 Mayo 2004 - 9:49PM
PR Newswire (US)
U.S. FDA Grants Orphan Drug Status to PI-88 for Melanoma BRISBANE,
Australia, May 3 /PRNewswire-FirstCall/ -- Progen Industries
Limited , a progressive Australian anti-cancer drug development
company, announced today that it has received orphan drug
designation from the U.S. Food and Drug Administration (FDA) for
their lead anti-angiogenesis product PI-88 for treatment of
malignant melanoma. Orphan drug designation will provide PI-88
seven years market exclusivity when approved for this disease
indication. The U.S. Orphan Drug Act is intended to encourage
companies to develop therapies for the treatment of diseases that
affect fewer than 200,000 individuals. Additional criteria include
the ability of the product to address unmet medical need where no
approved treatment option exists or, the provision of significant
benefit over other available treatments. Under the Act, upon
marketing authorization and during the period of market
exclusivity, the FDA does not accept or approve other applications
to market the same medicinal product for the same therapeutic
indication. In addition to potential market exclusivity, orphan
drug status provides up to 50% in U.S. tax credits, grant funding
for research and development and reduced filing fees, expedited
review as well as advice on the conduct of clinical trials. PI-88,
is one of a new class of multi-targeted cancer therapeutics
inhibiting both angiogenesis or tumor promoting factors such as
Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth
Factors 1 and 2 (FGF-1 and -2) and heparanase, an enzyme implicated
in tumor metastasis (tumor spread). PI-88 is undergoing a Phase II
clinical program in metastatic melanoma as a single agent therapy;
advanced non-small cell lung cancer (NSCLC) in combination with
chemotherapy (Taxotere(R)); as adjuvant treatment in post-
operative primary liver cancer (imminent); and as a single agent
therapy in multiple myeloma (completed). "We believe the strength
of PI-88 resides in its ability to inhibit both angiogenesis and
metastasis simultaneously and we have seen evidence that this
potential might be realized across a variety of cancers," stated
Robert Don PhD, Progen's VP of Research and Development. "The FDA's
orphan drug designation further strengthens our program for PI-88
by offering important accelerated clinical development and
commercialization benefits. We are pleased and gratified by the
Agency's support of our efforts to bring PI-88 to patients with
this deadly disease." DATASOURCE: Progen Industries CONTACT: Sarah
Meibusch of Progen Industries, +61-7-3273-9100,
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